DGAP-News
Apricus Biosciences Provides First Quarter 2013 Corporate Update
Apricus Biosciences, Inc.
10.05.2013 14:30
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Company to Host Conference Call/Webcast Today at 9:00 AM ET
SAN DIEGO, 2013-05-10 14:30 CEST (GLOBE NEWSWIRE) --
Apricus Biosciences, Inc. ('Apricus Bio' or the 'Company') (Nasdaq:APRI)
(http://www.apricusbio.com), today provided an update regarding ongoing
corporate activities and announced that it expects to file its Quarterly Report
on Form 10-Q for the quarter ended March 31, 2013 with the Securities and
Exchange Commission on Friday, May 10, 2013. As previously announced, the
Company will host its first quarter 2013 financial results conference call
today, May 10, 2013 at 9:00 a.m. ET.
'Apricus Bio began 2013 with a newly focused corporate strategy aimed at the
commercialization, through partnerships, of its lead product Vitaros(r) for
erectile dysfunction ('ED') and the development of its lead product candidate
Femprox(r) for female sexual arousal disorder ('FSAD'),' said Richard Pascoe,
Chief Executive Officer of Apricus Bio. 'Since the beginning of the year, we
have made important progress in support of that goal, including the successful
divestiture of multiple non-core assets, streamlining of our operations to
better align them with our objectives, and advancement of our regulatory and
commercial strategy for Vitaros(r) and Femprox(r). We continue to believe that the
greatest opportunity for shareholder value creation remains in the global
development and commercialization, through strategic partnerships, of these
lead assets.'
Recent Corporate Developments
-- European approval decision for Vitaros(r) in Europe via the Decentralized
Procedure ('DCP'). We are currently awaiting a decision regarding the
approval of Vitaros(r) in Europe via the DCP with The Netherlands serving as
the Reference Member State ('RMS'). In April of 2013, Apricus Bio, in
consultation with our European commercialization partners, submitted to the
RMS our response to the Day 120 List of Questions ('LOQ'). This week, which
marked Day 180 of the regulatory approval process, the RMS confirmed that
the major nonclinical, clinical and clinical safety issues outlined in the
Day 120 LOQ have been resolved. While the regulatory review process is
ongoing, and we remain in active dialogue with the RMS on certain remaining
matters included in the Day 180 response, we believe that the marketing
approval process for Vitaros(r) in Europe remains on track for an approval
decision on Day 210 of the process assuming there are no other
commercialization, through partnerships, of its lead product Vitaros(r) for
erectile dysfunction ('ED') and the development of its lead product candidate
Femprox(r) for female sexual arousal disorder ('FSAD'),' said Richard Pascoe,
Chief Executive Officer of Apricus Bio. 'Since the beginning of the year, we
have made important progress in support of that goal, including the successful
divestiture of multiple non-core assets, streamlining of our operations to
better align them with our objectives, and advancement of our regulatory and
commercial strategy for Vitaros(r) and Femprox(r). We continue to believe that the
greatest opportunity for shareholder value creation remains in the global
development and commercialization, through strategic partnerships, of these
lead assets.'
Recent Corporate Developments
-- European approval decision for Vitaros(r) in Europe via the Decentralized
Procedure ('DCP'). We are currently awaiting a decision regarding the
approval of Vitaros(r) in Europe via the DCP with The Netherlands serving as
the Reference Member State ('RMS'). In April of 2013, Apricus Bio, in
consultation with our European commercialization partners, submitted to the
RMS our response to the Day 120 List of Questions ('LOQ'). This week, which
marked Day 180 of the regulatory approval process, the RMS confirmed that
the major nonclinical, clinical and clinical safety issues outlined in the
Day 120 LOQ have been resolved. While the regulatory review process is
ongoing, and we remain in active dialogue with the RMS on certain remaining
matters included in the Day 180 response, we believe that the marketing
approval process for Vitaros(r) in Europe remains on track for an approval
decision on Day 210 of the process assuming there are no other